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Retigabine

Phase 2

Postherpetic Neuralgia | Small molecule | Other |Bausch Health Companies Inc.|Last Updated: May 8, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment187
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00612105Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)PHASE2 COMPLETED 187Oct 1, 2007Dec 1, 2009May 8, 201845 United States, South Africa
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Study Endpoints
Primary Endpoints
Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.
Baseline and Week 4 (Maintenance Phase-MP)

Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.

Secondary Endpoints
Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment
Baseline and Weeks 2 and 4 (Maintenance Phase - MP)
Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)
Weeks 1, 2, 3, and 4 Maintenance Phase
Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)
Baseline and Weeks 1, 2, 3, and 4 (MP)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRetigabine
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
RetigabineDRUG150mg/day up to 900mg/day
PlaceboDRUGdaily
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion Criteria: * Ability to provide informed consent * Male or female subjects * 18-85 years of age * PHN for more than 6 months after the healing of herpes zoster skin rash * Has a pain score at screening and randomization that qualifies Exclusion Criteria: * Other significant pain that may...

Countries:United StatesSouth Africa
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